Actively Recruiting
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
Led by GlaxoSmithKline · Updated on 2025-10-08
981
Participants Needed
15
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.
CONDITIONS
Official Title
Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 80 years at the time of informed consent
- Elevated blood eosinophil count
- Moderate to severe COPD with a clinical diagnosis for at least 1 year
- Post-bronchodilator FEV1/FVC ratio less than 0.70, and FEV1 greater than 30% and less than or equal to 80% of predicted normal
- At least 2 moderate or 1 severe COPD exacerbations in the 12 months prior to screening
- COPD assessment test (CAT) score of 10 or higher at Visit 1
- Current or former cigarette smoker with at least 10 pack-years
- On optimized inhaler therapy (ICS plus LAMA plus LABA) for at least 6 months prior to screening
- Body mass index (BMI) of 16 kg/m2 or higher
- Male or eligible female participants
You will not qualify if you...
- Current or prior diagnosis of asthma
- Other significant lung diseases where COPD is not the primary diagnosis
- Pneumonia, COPD exacerbation, or lower respiratory tract infection within 4 weeks prior to screening
- History of, or planned, lung volume reduction surgery or endobronchial valve procedure
- In acute phase of pulmonary rehabilitation within 4 weeks prior to screening
- Requires oxygen supplementation for more than 12 hours per day
- Cor pulmonale causing right heart failure or severe pulmonary hypertension
- Chronic hypercapnia requiring non-invasive ventilation (BiPAP or CPAP)
- Unstable cardiovascular disease or arrhythmia
- Known parasitic infection within 6 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
GSK Investigational Site
Loxahatchee Groves, Florida, United States, 33470
Actively Recruiting
2
GSK Investigational Site
Miami, Florida, United States, 33155
Actively Recruiting
3
GSK Investigational Site
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
4
GSK Investigational Site
Corsicana, Texas, United States, 75110
Actively Recruiting
5
GSK Investigational Site
Changsha, Hunan, China, 410015
Actively Recruiting
6
GSK Investigational Site
Chengdu, Sichuan, China
Actively Recruiting
7
GSK Investigational Site
Chengdu, China, 610041
Actively Recruiting
8
GSK Investigational Site
Guangzhou, China, 510150
Actively Recruiting
9
GSK Investigational Site
Hangzhou, China, 310000
Actively Recruiting
10
GSK Investigational Site
Jiangmen, China, 529000
Actively Recruiting
11
GSK Investigational Site
Jiangxi, China
Actively Recruiting
12
GSK Investigational Site
Mianyang, China
Actively Recruiting
13
GSK Investigational Site
Qingyuan, China, 511500
Actively Recruiting
14
GSK Investigational Site
Zigong, China, 643036
Actively Recruiting
15
GSK Investigational Site
Tokyo, Japan, 140-8522
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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